Pilot Scale SFC System SFC-DAC Column · [email protected] (7 40) 444 -HEMP GLOBAL...

[email protected] (740) 444 -HEMP

GLOBAL HEMPSOLUTIONS

Pilot Scale SFC System &

SFC-DAC Column



1. Quotation ..................................................................................................... 1

Quotation ............................................................................................. 1

2. System Configuration and Technical Specifications ............................... 2

Project Introduction ........................................................................... 2

General Appearance .......................................................................... 3

Introduction System Description ..................................................... 4

System PI&D Drawing ................................................................ 4

Product Features ........................................................................ 4

Main Components Configuration Tables ....................................... 5

Main Components Description.................................................... 6

DAC-HB50Dynamic Axial Compression Column Description ........ 9

Appearance Picture .................................................................... 9

Cylinder Components ............................................................... 10

Piston Components .................................................................. 10

Control System ......................................................................... 12

Hydraulic system PI&D Drawing ............................................... 12

Column Tube .................................................................................. 12

Control System Description............................................................ 14

The Configuration Tables of Control system ............................. 14

Key Parts of Control System ..................................................... 16

Control Software ............................................................................... 17

3. Other Project Requirements .................................................................... 18

System Other Requirements.............................................................. 18

Accompanying Documents Items ...................................................... 19

4. After-sales Requirements ........................................................................ 19

5. Company Profile ....................................................................................... 20

Table of Contents



1.1Quotation

Equipment Name Configuration Unit QTY Total Price CS-Industrial SFC purification

system CS-SFC180 Set 1

Dynamic Axial Compression Column

DAC-SFC50 Set 1

Air Shipped and Installation in the USA

S&I-USA Set 1

TOTAL USD

Special Notes:

1. Shipping to US Port and Installation guidance are INCLUDED andcovered by manufacturer. Transit from US Port to client facility notincluded. Additional taxes, fees, tariffs are not included

2. Manufacturer will provide 2 years quality warranty.

1.Total Quotation

Included

Included

Included


GLOBAL HEMP

SOLUTIONS

Super-critical Fluid Chromatography (SFC) uses the super-critical fluid as

the mobile phase. The fluid not only has viscosity and high diffusion coefficient

close to the gas ， but also has high density and strong dissolving ability close

to the liquid. So the SFC combines the advantages of both GC and HPLC. The

chromatographic stationary phase used for SFC is similar to liquid

chromatography. The mobile phase is typically a mixture of CO₂ and an

organic solvent (methanol, etc.). It not only can separate thermally unstable,

high molecular weight, strongly polar or non-volatile compounds which is

difficult to separate by GC, but also can separate high molecular weight

compounds which are difficult to separate by HPLC. Because of its unique

advantages and characteristics, SFC has been very extensive research and

application.

Based on the requirements of the Super-critical Fluid Chromatography

(SFC) system, this project completes its DDS, and finally designs

equipment that meets the needs of separation and purification of raw

materials for customers. The system includes:

Fluid delivery modules (including CO₂ pump and organic solvent pump)

Injection modules

High-pressure DAC modules

High-pressure UV detection modules

Back pressure control modules

CO₂ recovery modules

Control and data processing modules

2. System configuration and Technical Specifications

2.1 Project Introduction



General Appearance

CS-Industrial ATEX SFC purification system （The specific dimension will be confirmed on DQ Design Documents）



Infusion system unit description

2.3.1 System PI&D Drawing

Product Features

The supercritical fluid chromatography (SFC) system was developed based

on an industrial preparative HPLC. It can be used to separate chiral

compounds, any complex mixtures or natural extracts ranging from grams

to tens of kilograms.


GLOBAL HEMPSOLUTIONS Efficiency:

The efficiency of Supercritical fluid chromatography is usually 3 to 5 times

the traditional preparation of chromatography, which can speed up the

separation of compounds from grams to kilograms to meet the needs of

the medical chemistry to its clinical trials.

Performance：

From the selection of engineering components to final assembly and site

installation, we have complete control over the entire process of designing,

manufacturing and testing the system to provide you with the best

performance guarantee.

Reduce the influence of the environment.

The use of supercritical CO2 reduces the consumption of organic solventsby 5 to 20 times, and our unique CO2 recycling technology allows you todramatically reduce CO2 consumption up to 20 times, while reducingproduction costs and environmental impact.

Main components configuration tables

Item Specifications QTY Brand Origin

CO2 Pump Diaphragm pump，Wetted Material：316 SS steel/PTFE, Max flow ： 120LPH ， Max Pressure：30MPa

1pcs LEWA Germany

CO2Pump Flowmeter

Brand：E+H Promass Mass Flowmeter Accuracy：±0.15% 1pcs E+H Germany

CO2Pump Pressure sensor

Pressure setting range：0~30MPa，Accuracy：±0.15%，Signal Output：4...20 mA

1pcs E+H Germany

Injection Pump Piston Pump ， Wetted Material ： 316 SS Steel/PTFE, Max Flow ： 30LPH ， Max Pressure：30MPa

1pcs HAMBOM China

Modifier Pump Diaphragm pump, Wetted Material ： 316 SS Steel/PTFE, Max flow ： 60LPH ， Max Pressure：30MPa

1pcs LEWA Germany

Modifier Pump Flowmeter

Brand：E+H Promass Mass Flowmeter Accuracy：±0.15% 1pcs E+H Germany

Modifier Pump Pressure Sensor

Pressure setting range：0~30MPa，Accuracy：±0.15%，Signal Output：4...20 mA

1pcs E+H Germany

Back Pressure Back Pressure setting range：0~40MPa 1pcs Masoneilan Germany



Item Specifications QTY Brand Origin Valve

PLC Electrical Control System

PLC components, including PLC controller (Siemens, Germany), CPU modules, power modules, input and output modules, memory cards and other components

1pcs Siemens Germany

Electrical components system piping, fittings and other accessories, including: air switch, AC contactor (SCHNEIDER France), phase failure and phase sequence protection relays, fuse holders, switching power supply, etc.

1pcs SCHNEIDER

Germany

IPC， Core Duo E5300 / memory 2G / hard drive 160G / DVD drive

1pcs Avantech Taiwan

Electrical cabinet: Material: SUS304, matte finish

1pcs HAMBOM China

Others: Liquid crystal display (HP), buttons, lights, wires, etc. Protection level: IP65

1pcs HP USA

Chromatography Work Station

Second development based on GE platform Which is control and data processing integrated software, conforming to FDA and GMP requirements, with multi-level user permissions, manual control, alarm settings and other functions, detailed records of system operation log, real-time display of operating parameters, flow path status, Various detection curves, graphical user interface, data can be automatically recorded and stored, copy, process records and report print output, the original data can’t be changed

1pcs HAMBOM China

Main Components Description

2.3.4.1Infusion Pump

German LEWA diaphragm pump, Pressure resistance is up to 20Mpa, the

designed working temperature is not less than 60℃and the designed standard

satisfied with ATEX relevant requirements; The internal surface roughness

satisfied with SF4 level requirement, The materials that contact all liquid and



medium is not less than 316L, Explosion-proof standards for design:

ExdIIBT4;

Characteristics: Maintenance costs are very low and maintenance interval

period is very long; Mechanical efficiency is very high; the security of

Resistance to overload is very high; Stroke adjustment doesn't need too much

energy; Stroke control linear is very good. When it is running, you can also

adjust the stroke. It can provide a variety of drive configuration and pipeline

connection scheme to you. It is equipped with high pressure protection valve.

When the pressure is over than the maximum working pressure (200bar or can

set by the operators), the system will stopped automatically and release the

over pressure by waster liquid outlets and protect the system. The check valve

material is SUS316L, PTFE.

Mass flow meter

E+H Promass Mass flow meter from Germany is a multivariate flow rate

measurement system and can be measured by liquid or gas. Explosion the



authentication: ATE, FM, CSA, TIIS. Food industry Explosion

authentication/health requirements:3A,FDA; Multivariate measurement: It

can simultaneously measure the mass flow rate and density.

Accuracy: liquid±0.15%，Gas：±0.50%

Pressure Transmitter

Brand ： E+H ， Stroke ： 0-10Mpa .E + H, one of the world's largest

professional manufacturer of pressure and temperature measurement

instruments and equipment.

Back Pressure Regulating Valve

Brand: MASONEILAN (Masoneilan).


2.4 SFC-DAC-HB50 Dynamic Axial Compression

Column Description

2.4.1 Appearance Picture

SFC-DAC-ID50/80mm

Pneumatic flow regulating valve features：

(1) Erosion-resistant, flash-resistant.(2) Shut off tight, seal level can reach ANSI.

(3) High reliability: unbalanced spool and top guide stem design to

ensure that the valve can achieve maximum stability even in harsh conditions.

(4) High efficiency: 21000 series through the interior design, actuator

stability and closure of the integration to achieve the most appropriate control

performance. It also offers a completely efficient valve platform using a wide

range of materials, pressure ratings and valve end connections.

(5) A variety of different forms of internal options, such as noise

reduction, anti-cavitation.

(6) Simple structure, easy maintenance.


The dynamic axial compression column consists of the following components:

1. Cylinder parts 2.Supporting parts 3. Piston parts 4.Tube parts 5. Frame parts 6.

Control system 7. End cap parts 8. Chain clamps part.

2.4.2 Cylinder parts

Hydraulic cylinder jacket material: 45#steel ， Thermal refining ： 25 ～

30HRC. Adopt the automatic welding, detection treatment; ensure no leakage

porosity and welding defects.

Piston rod ： Hard chromium plating surface treatment, plating chromic

layer in the atmosphere and has stronger passivation ability, can keep the

metal luster, It can't produce the chemical reaction in a variety of acid

medium. Coating hardness will be reached to 1000 HV, excellent wear

resistance

Seal ring: the Parker precision O-rings and block circle, and to ensure the

hydraulic cylinder will not have the leakage under high pressure and longtime

wear-resisting performance.

The hydraulic cylinder surface: the primer is the anti-rusting paint, paint

processing outer lacquer.

The hydraulic cylinder strictly comply with JB/T 10205-1500 “The

inspection standard of hydraulic cylinder technology conditions". Under the

35MPa pressure, there is no external and internal leakage.

The hydraulic oil: the viscosity is 46 ~ 68 CST, anti-wear hydraulic oil.



Piston Parts

Piston main parts: Seat Connection, orientation cycle, and active sealing rings,

bowl type seal ring, distributor, type of mesh filter board, O-rings, etc.

Piston parts material: SUS316L/PTFE/PEEK, all materials meet FDA, NSF

standards and the bolt connection between piston and cylinder, very easy to

dismounting and the floating piston design will eliminate the coaxial tolerance

between hydraulic cylinder and column tube.

The pistons used the three seals design, bowl type of seal ring and active

sealing ring and oriented ring, all these will ensure the column tube sealing

performance;

The piston distributor adopted H-Tree style, the end cap of column tube

design adopted the sector distribution methods, and to ensure the fluid will be

converged rapidly



Control System Adopting imported gas, oil circuit component; improve the sealing performance of the entire system, no leakage, high reliability, while improving product life.

Hydraulic system PI&D Drawing

1、Air compressor 2、Filter 3、Air source Main Switch 4、Air Pressure Regulation Valve 5、Barometer 6、Pneumatic pump 7、Overflow valve 8、Barometer 9、Pneumatic four way valve 10、Hydraulic cylinder

Column Tube

It is using the most advanced domestic grinding technology, it can guarantee

that column wall roughness will be ≤ 0.02 mm, also greatly enhance the degree

of finish and reduce the column wall effect to improve the performance of

column.



No. Name Specification／Material／Brand／Requirements QTY 01 Frame Material 304 SS Steel 1

02 Column Tube

Material 316 SS Steel

1

Column diameter 50mm，Design Pressure 30MPa,with heating jacket

Length 650mm Polishing degree Inner surface Ra≤0.2μm，extra surface Ra≤1.4μm

03 End cap

Material 316 SS Steel —— Seal ring Material: O-ring (FEP + SI) 2 Polishing degree

Inner surface Ra≤0.2μm，extra surface Ra≤1.6μm ——

Distributor 316 SS Steel Sector distribution methods, to ensure the fluid will be converged rapidly

1

Frit 316 SS Steel Pore size：2~3um

1

04 Piston

Material 316 SS Steel —— Distributor Material：316 SS 1

Frit 316 SS Steel Pore size：2~3um

1

Seal ring Material: O-ring (FEP + SI) 2

05 Compressio n System

Control Panel

304 SS Steel 1

Pressure Gauge

Brand：MAXIMATOR；Stroke：0-250BAR/PSI Accuracy：5BAR

1

Pneumatic Pump

Brand： MAXIMATOR 1pcs

Manual Brand：EAGLE The manual four-way valve controls 1pcs



four-way valve

the direction of the hydraulic stem movement

Check valve Brand：EAGLE 1pcs Pressure retaining valve

Brand：EAGLE 1pcs

06 Pneumatic Module

General air source switch

Brand：Legris 1pcs

Pressure regulating valve/ Oil-water separator

Brand：SMC；Regulating the pressure of the air source

1pcs

No. Requirements

01 Column tube made of seamless steel tubes, the inner surface adopt quilting, grinding, elector-polishing, polishing method, to ensure no material off, no red rust, dark spots.

02 All welding parts are fully automatic welding, electric polishing or mechanical polishing, to ensure smooth surface, no burrs.

03 Connecting the end cap and column with chain clamp, connecting column and frame with claps, easy to disassemble, chain clamp material: 304 SS Steel, polished. Nut Material: 304 SS Steel

04 Pressure regulating valve adjust gas pressure and oil pressure to appropriate position, can be locked.

05 Pipe joints adopt quick change connector, easy to disassemble.

06 Liquid Drainage Line Material: PTFE metal hose, fixed with piston and column bottom through stainless steel head, easy to disassemble and no liquid leakage.

07 Equipped with a gas source connection pipeline, a set of solvent pipeline while packing column, pipeline material: PTFE metal hose.

Control System

The configuration tables of Control parts

No. Name Design, Manufacturing Standard

01 On-line control

It is combined by the keyboard of positive pressure explosion-proof and LCD screen. The operators can set up the flow rates and then start the Infusion pumps. If there is an abnormal problem, the pumps can be stopped by operation of keyboard and the display screen can display flow rates.


02 Local Control

Valves Control

All kinds of valve switching will be controlled by the connection of Computer and PLC in order to realize all kinds of liquid selection and trend.

Pressure and flow control

PLC will read pressure transmitter, Mass flow meter current electricity output, display system pressure, control and display different solvent flow.

Emergency Brake Control

System has an emergency break switch which can rapidly stop the system if an emergency occurs. After the treatment of system problems, the system will be recovered to the previous process. It has the emergency stop button and can easily touch it and stop the system according to the requirements.

03 Software Configuration

Meet FDA CRF part II related requirements with historical records, all data has the traceability, It can keep record of all operation status.

04 Interfa ce

Overall Require ments

Including monitoring procedures, operating procedures and external equipment; User control system can ensure the safe, reliable and continuous; Automatic control system is safe, easy to operation, the structure is reasonable, Through the line or other way connection, can be in equipment remote operation and monitoring.

Monitori ng

interface

Display the running state of the equipment (such as: preparation, operation, stop, etc.), Display system running program process (such as: the stage operation, operation etc.), Display equipment real-time online detection data, including pressure, flow rates, UV detector;

Others It can set the alarm

05

Data Acquisi tion and store

Data acquisiti

on

Automatic record and storage Data can be preserved and kept record Process record printout The report printout Data is reliable Raw data cannot be changed

Data need to

be collecte d and

automa tic

recorde d.

Valves in and out position and switch status Column Position Pipeline flow direction Flow rates Pressure UV Absorption (preserve the chromatogram) Alarm information Operation and program operation record Gradient elution curve

Data preserva tion

Provide the system data storage medium capacity size requirements


Key Parts of Control system 2.5.2.1

Industrial control computer

Advantech from Taiwan, China

19 "rugged 4 u mounted case, it is equipped with 14 passive back plane or

industrial motherboard, the resistant disk drive bays can support three 5.25"

and one 3.5 "disk drive, the front end is equipped with two USB or PS / 2

keyboard I/O interface, the system status LED indicator on the chassis front

panel can display power supply, hard disk, and the operation of the system

voltage, the blowing cooling fan can maintain positive air circulation within

the whole case. Due to these characteristics, it makes the system have the

stronger anti interference, dustproof, shockproof, anti-interference flowability.

PLC Control system

Siemens PLC controller: the maintenance workload is small, easy

maintenance, low failure rate, and can improve the diagnosis and display

function. PLC or external input device has failure with actuator, the operators


can quickly find out the cause of the failure according to the light emitting

diode or PLC programmer information and use replacement modules can be

ruled out so quickly

Siemens Frequency Converter

Siemens MM4 series drives have a simple, modular design that allows

maximum flexibility in configuration, with three fully programmable, isolated

digital inputs, complete inverter and motor protection.

Control software

System software developed based on GE's software platform, the software

features as following

• Friendly graphical user interface, online real-time display of the various

parameters during operation, such as time, flow, flow rate;


3. Other Project Requirements

3.1 System other requirements

• Good operation interface, easy to achieve a variety of functions

• Multi-mode operation can be selected, debug mode, manual mode and

automatic mode;

• Comprehensive data operation log to ensure that every step can be

traced back;

• GLP/FDA-21CFR Part II fully support GLP/FDA-21 CFR Part II• Strictly distinguish user's operation authority, in case operator's change

of production data;

• Multiple Tasks Hyper-Threading Data Processing System, fast system

response and fast processing;

• High precise data acquisition and processing to ensure the accuracy of

the chromatographic calculation results.

NO Requirements

01 All the measurement use metric system.

02 Supplier should provide a control platform with a stable system performance,

and equip necessary communication interface.

03 Supplier should provide related software instruction files of program development, encoding procedure usage and so on.

04 Supplier should list the power supply, which meet the usage of equipment and other requirements of utility system.

05 Equipment running noise is less than 100bd ( within three inch from

equipment)

06 This equipment should be provided with the ability of anti-electromagnetic

interference and radio wave interference. The release and electromagnetic

interference should meet the requirements of CE certification.

07 All the material contact with products should meet requirements of current EU

cGMP, FDA, cGMP, USP Class Ⅵ and Chinese GMP.

08 All the pipeline’s welding points which contact with products should meet the

requirements of current ASME BPE specification.

09 The material of system pipeline is polypropylene or similar polymer system,


the material of pipeline gasket/joint ring should be EPDM or PTFE.

10 Suppler should provide supporting documents and Compatibility list of

material of system.

11 The whole surface of system should meet the requirement of wipe disinfection

and air sterilization.

12 All the assembly, control circuit, connecting line etc. should be marked and

easy to be identified.

No Names QTY 01 Qualification of equipment supplier and quality assurance files 1pcs 02 Qualification of relevant assembly supplier and supporting files. 1pcs 03 Material report 1pcs

04 DQ－Design Qualification (DQ) 1pcs

05 FAT－Factory acceptance test 1pcs

06 SAT－Customer site acceptance test 1pcs

07 Installation Qualification (IQ) 1pcs

08 Performance Qualification (PQ) 1pcs

09 Operational Qualification (OQ) 1pcs

10 Installation manual 1pcs

11 Operational Manual 1pcs

12 Packing list 1pcs

13 Spare parts list 1pcs

Other requirements

No. Requirements

14 DQ/FAT/SAT scheme should be provided to user and sign to confirm, then next step work can be conducted.

No. Requirements 01 Provides computer program CD backups 1pcs 02 Provides computer and PLC data line 1pc for each 03 Provides Written equipment maintenance, maintenance plan

04 Provides record and control software maintenance plan

05 Provides the equipment maintenance tools 1set

3.2 Accompanying documents items

4. After-Sales Service Requirement


06 Supply of equipment spare parts within the service life and provide preferentialsupply commitment.

07 Provide one year of equipment warranty and lifetime maintenance services.

08 Free to provide assistance to debug, start support services, including

assistance in installation, operation and commissioning.

09 If Equipment is failed, we shall respond upon receipt of notification within 24

hours rushed to the site within 72 hours to solve the problem.

10 To provide users with equipment excellent performance that meet the user's

technical parameters

11 After Equipment is arrival, the internal connection of pipeline and control line installation, public line connection.

12 Regular inspection on equipment, freely assist the equipment examination and

basic maintenance without additional cost.

13

Equipment supplier is responsible for user training, and the content includes:

--- SFC basic principle; equipment basic composition

--- Understanding of each component of the new technology

--- Assembly and disassembly on DAC column and internal structure

--- The operation status under the running

--- Operating system interface and method of operation

--- Equipment daily maintenance;

--- Equipment failure analysis method and solving steps

14 Equipment supplier provides wearing parts, consumable list, the use of brand

and specifications/model

5、Company Introduction


Manufacturer is located in China was established in 1998, which is a largest professional Preparative HPLC system and DAC/SAC column and SMB manufacturer in China. We are specially majoring in Products research, Methods development and Lab and Industrial Scale Prep HPLC system and DAC column production and relevant continuous chromatography equipment.

CS-Prep500 HPLC system with diaphragm pump at customer’s site

Production Scale SFC system with diaphragm pump


The company includes more professional Labs for samples analysis, Preparative process scale-up, process optimization, QC and so on. It is focused on technology innovation and Prep Chromatography equipment construction. Our manufacturer has more than 200 employees who are engaged in Preparative Chromatography Industry. All these are very professional and technical.

In 2005, the first Chinese DAC column with our Chinese first intellectual property patent was developed by the Manufacturer. In 2006, the simulated moving bed chromatography equipment for sugar alcohol, chemical and pharmaceutical industries was successively developed by us with their patents.

The development of five separation projects for Chromatography Industry was listed on the "2006 Science & Technology Project" and also on the "2006 Innovative funds project" and other awards. Our manufacturing facility has more than 13 patents, 3 high tech products in china and 20 registration trademarks.

In 2009, they established the "Biological Process Control center" with the Chinese Academy of Sciences (CAS). All these are the first in china. At the same time, we are establishing the best long-term business relationship with many famous International Pharmaceutical companies in the world.

CS-Prep HPLC system with DAC-ID500mm Column


5. Part of SFC customer list

No. Client Name SFC-Prep

HPLC SFC-DAC Size Qty（set）

1 Beijing Academy of Military Sciences

Prep DAC-150 1

2 Beijing 301 Hospital Prep DAC-50 1

3 Shenzhen Xinlitai Prep DAC-150 1

4 Nanjing Shenhe Pharmaceutical Prep DAC-100 1

5 Suzhou University Prep DAC-100 1

6 Hangzhou Huajinyunshang

Pharmaceutical Prep DAC-100 1

7 Shanghai Deyi Biology Prep DAC-150 2

8 Anygen from Korea Prep DAC-100/150(2)/

200 4

9 Sanofi from France Prep DAC-80/150 2

10 Teva from Hungary Prep DAC-150 2

11 Ambio peptide from USA Prep DAC-300 2

12 Lonza from Switzerland Prep DAC-300 1

13 Dr. Reddy Lab from India Prep DAC-150/600 2

14 Bachem from Switzerland Prep DAC-450 1

15 Hetero drugs from India Prep DAC-50/80 3

16 Cargoen from Switzerland Prep DAC-50/150 2

17 Evonik from Germany SMB DAC-80 1

18 Laurus Lab from India Prep DAC-50/100/200 3

Pilot Scale SFC System SFC-DAC Column · [email protected] (7 40) 444 -HEMP GLOBAL...

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Transcript of Pilot Scale SFC System SFC-DAC Column · [email protected] (7 40) 444 -HEMP GLOBAL...